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ACTIVE NOT RECRUITING
NCT06563700
NA

Novel Lenses for Myopia Progression Trial

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

Summary

This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.

Official title: A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia

Key Details

Gender

All

Age Range

7 Years - 13 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-08-16

Completion Date

2027-07-31

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

OTHER

spectacle lens

one of ZEISS BD spectacle lens designs 1 to 5

OTHER

single vision lens

single vision lens

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China